Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, P.R. China.
Cancer Med. 2023 Jul;12(14):15000-15010. doi: 10.1002/cam4.6136. Epub 2023 Jun 16.
We launched a single-arm phase II study to determine the efficacy and cost-effectiveness of percutaneous endoscopic gastrostomy (PEG) before concurrent chemoradiotherapy (CCRT) in patients with esophageal squamous cell carcinoma (ESCC).
Eligible patients received pretreatment PEG and enteral nutrition during CCRT. The primary outcome was the change of weight during CCRT. The secondary outcome included nutrition status, loco-regional objective response rate (ORR), loco-regional progression-free survival (LRFS), overall survival (OS), and toxicities. A 3-state Markov model was applied for cost-effectiveness analysis. Eligible patients were matched and compared with those who had nasogastric tube feeding (NTF) or oral nutritional supplements (ONS).
Sixty-three eligible patients received pretreatment PEG-based CCRT. The mean change of weight during CCRT was -1.4% (standard deviation, 4.4%), and after CCRT, 28.6% of patients gained weight and 98.4% had normal albumin levels. The loco-regional ORR and 1-year LRFS were 98.4% and 88.3%. The incidence of grade ≥3 esophagitis was 14.3%. After matching, another 63 patients were included in the NTF group and 63 in the ONS group. More patients gained weight after CCRT in the PEG group (p = 0.001). The PEG group showed higher loco-regional ORR (p = 0.036) and longer 1-year LRFS (p = 0.030). In cost analysis, the PEG group showed an incremental cost-effectiveness ratio of $3457.65 per quality-adjusted life-years (QALY) compared with the ONS group with a probability of cost-effectiveness of 77.7% at the $10,000 per QALY willingness-to-pay threshold.
Pretreatment PEG is associated with better nutritional status and treatment outcome in ESCC patients treated with CCRT compared with ONS and NTF. Pretreatment of PEG can be cost-effective because of its significant clinical benefits.
我们开展了一项单臂二期研究,以确定在接受同步放化疗(CCRT)的食管鳞状细胞癌(ESCC)患者中行经皮内镜胃造口术(PEG)的疗效和成本效益。
符合条件的患者在 CCRT 期间接受预处理 PEG 和肠内营养。主要结局是 CCRT 期间体重的变化。次要结局包括营养状况、局部客观缓解率(ORR)、局部无进展生存期(LRFS)、总生存期(OS)和毒性。应用三状态 Markov 模型进行成本效益分析。符合条件的患者进行匹配,并与接受鼻胃管喂养(NTF)或口服营养补充(ONS)的患者进行比较。
63 名符合条件的患者接受了基于 PEG 的预处理 CCRT。CCRT 期间体重的平均变化为-1.4%(标准差为 4.4%),CCRT 后,28.6%的患者体重增加,98.4%的患者白蛋白水平正常。局部 ORR 和 1 年 LRFS 分别为 98.4%和 88.3%。≥3 级食管炎的发生率为 14.3%。匹配后,NTF 组和 ONS 组各纳入 63 名患者。CCRT 后,PEG 组更多的患者体重增加(p=0.001)。PEG 组局部 ORR 更高(p=0.036),1 年 LRFS 更长(p=0.030)。在成本分析中,PEG 组每增加一个质量调整生命年(QALY)的增量成本效益比为 3457.65 美元,而 ONS 组在 10000 美元/QALY 的意愿支付阈值下,成本效益的概率为 77.7%。
与 ONS 和 NTF 相比,在接受 CCRT 的 ESCC 患者中,PEG 预处理与更好的营养状况和治疗结局相关。由于其显著的临床获益,PEG 预处理具有成本效益。